NAT-OSELTAMIVIR POWDER FOR SUSPENSION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE)

Dostupné s:

NATCO PHARMA (CANADA) INC

ATC kód:

J05AH02

INN (Mezinárodní Name):

OSELTAMIVIR

Dávkování:

6MG

Léková forma:

POWDER FOR SUSPENSION

Složení:

OSELTAMIVIR (OSELTAMIVIR PHOSPHATE) 6MG

Podání:

ORAL

Jednotky v balení:

15G/50G

Druh předpisu:

Prescription

Terapeutické oblasti:

NEURAMINIDASE INHIBITORS

Přehled produktů:

Active ingredient group (AIG) number: 0139501005; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2020-06-05

Charakteristika produktu

_Page 1 of 50 _
PRODUCT MONOGRAPH
PR
NAT-OSELTAMIVIR
oseltamivir capsules
oseltamivir phosphate capsules, USP
30 mg, 45 mg and 75 mg oseltamivir (as oseltamivir phosphate)
oseltamivir powder for oral suspension
6 mg/mL oseltamivir (as oseltamivir phosphate) when reconstituted
Antiviral Agent
Natco Pharma (Canada) Inc.
2000 Argentia Road, Plaza 1, Suite 200
Mississauga, Ontario
L5N 1P7
Date of Revision:
September 18, 2020
Submission Control No: 223389
_Page 2 of 50 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................
3
CONTRAINDICATIONS
................................................................................................
4
WARNINGS AND PRECAUTIONS
...............................................................................
4
ADVERSE REACTIONS
.................................................................................................
7
DRUG INTERACTIONS
...............................................................................................
13
DOSAGE AND ADMINISTRATION
...........................................................................
14
OVERDOSAGE
.............................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 22
STORAGE AND STABILITY
.......................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 21
PART II: SCIENTIFIC INFORMATION
.............................................................................
23
PHARMACEUTICAL INFORMATION
.......................................................................
23
CLINICAL TRIALS
..........................................